Pioglitazone for Lung Cancer Chemoprevention

Study summary

This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedfluorescence bronchoscopy and quantitative high resolution CT scan

Plus 1 other study approaches.

Who it may be forLung Cancer · Endobronchial Dysplasia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 11, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?VA Office of Research and Development

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Phase 2
Sponsor: VA Office of Research and Development
Interventions being studied: Procedure: fluorescence bronchoscopy; Procedure: quantitative high resolution CT scan; Drug: PIOGLITAZONE VS. PLACEBO 30 mg

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Current or former smoker (at least 10 pack years);
One or more of the following:
Mild or worse sputum atypia
Airflow Limitation (FEV1/FVC\<70% predicted)
Biopsy proven airway dysplasia

Reasons someone may not be able to joinExclusion criteria

myocardial infarction (MI) with ejection fraction \< 50%;
severe/unstable angina;
history of coronary or peripheral arterial bypass grafting;
New York Heart Association (NYHA) class III or IV congestive heart failure;
hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
life expectancy \< 6 months; history of bladder cancer
pregnant or breast feeding; inability to give informed consent

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

VA Eastern Colorado Health Care System, Denver, CODenver, Colorado
Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 11, 2019. Always confirm current availability with the study team.

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